Pharmacovigilance is a high-stakes, high-pressure process. With the rising number of adverse event reports and regulatory expectations, safety teams are under constant stress to handle more work, more accurately, and faster than ever before.
That’s where pharmacovigilance automation steps in—and changes everything.
🤖 What Is Pharmacovigilance Automation?
It’s the use of technology like AI, machine learning, and robotic process automation (RPA) to speed up routine safety processes. Instead of manually checking, sorting, and processing hundreds of safety reports, automated systems do the heavy lifting—faster and with fewer errors.
📦 Bulk Case Handling Without the Burnout
One of the most time-consuming parts of PV is triaging high volumes of ICSRs (Individual Case Safety Reports). These come in from multiple sources and in XML formats that need parsing, validating, and sorting.
Automation handles it in seconds, doing things like:
Recognizing valid vs. invalid cases
Flagging serious reports for urgent review
Detecting duplicates and follow-ups
Splitting and converting XMLs for easy intake
Bifurcating MAH (Marketing Authorization Holder) and Non-MAH cases
📜 Staying Compliant with Global Regulations
Health authorities like the FDA, EMA, and MHRA expect timely, error-free submissions. Manual errors, delays, or missed cases can lead to audits, warnings, or worse.
Automation ensures every step is logged, traceable, and aligned with guidelines like ICH E2B(R3).
⚙️ PvEdge®: Built for Pharmacovigilance Automation
If you’re looking to automate intelligently, PvEdge® is worth a look. It’s a platform made for real-world PV challenges. The triage module helps teams:
Ingest and process XMLs at scale
Run automatic seriousness and validity assessments
Detect duplicates and follow-up cases
Prepare cases for database entry — all without manual work
This isn’t just a tech upgrade—it’s a safety net for your PV operations.
💡 Why It Matters
70–80% time saved on bulk triage
Fewer human errors in case assessments
More focus on medical review and decision-making
Faster submissions = better patient safety
Pharmacovigilance automation isn’t just about doing things faster—it’s about doing them smarter, safer, and at scale.
